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Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI (CogMind)

Primary Purpose

Mild Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Plasticity-Based Adaptive Cognitive Training
Commercially available computerized training
Mindfulness Training
Traumatic Brain Injury Information Session
Sponsored by
Posit Science Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must be 18 years of age or older
  • Participants must have diagnosis of mild traumatic brain injury (mTBI) confirmed by Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF)
  • Participants must have persistent cognitive dysfunction confirmed by an objective measure (Automated Neuropsychological Assessment Metrics (ANAM) TBI Battery with a score at least one standard deviation below the age-adjusted norm for a military sample) or a subjective measure (Ruff Neurobehavioral Inventory (RNBI) with a score of greater than 70 on any of the four cognitive scales (Attention, Memory, Language, Executive)
  • Participants must be at least six months out from their most recent traumatic brain injury (TBI), concussion, and/or blast exposure
  • Participant must be a fluent English speaker
  • Participants must score ≥ 70 on the Wechsler Test of Adult Reading (WTAR)
  • Participants must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse

Exclusion Criteria:

  • Participants with history of TBI with loss of consciousness for more than 24 hours or post-traumatic amnesia for more than 7 days
  • Participants with a history of penetrating head wounds
  • Participants who are in-patients
  • Participants with a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis)
  • Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Participants showing signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
  • Participants with clinically significant visual field deficits
  • Participants judged to be lacking effort
  • Participants with problems performing assessments or comprehending or following spoken instructions
  • Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment for TBI that could affect the outcome of this study
  • Participant with self-reported claustrophobia or physician-reported implanted devices (e.g. pacemakers, cochlear implants, aneurysm clips, etc.) and pregnant women will not be able to participate in MRI portion of study.

Sites / Locations

  • Veterans Affairs Connecticut Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Treatment

Active Comparator

Arm Description

Computerized plasticity-based adaptive cognitive training and mindfulness training requiring a total maximum of 60 treatment sessions, up to 5 sessions per week, 40 minutes per session.

Commercially available computerized training and traumatic brain injury information session requiring a total maximum of 60 treatment sessions, up to 5 sessions per week, 40 minutes per session.

Outcomes

Primary Outcome Measures

Changes in performance on global cognitive composite score
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.

Secondary Outcome Measures

Changes in performance on processing speed composite score
Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks.
Changes in performance on memory composite score
Change in performance on memory will be measured using the composite score created by averaging the z-scores of N-Back task, Spatial Working Memory task, WAIS-IV Digit Span and Rey Auditory Verbal Learning Test (RAVLT).
Changes in performance on executive function composite score
Change in performance on executive function will be measured using the composite score created by averaging the z-scores for the Trail Making, Flanker, and Stroop tasks.
Change in functional performance
Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.
Change in TBI functional status
Between-group magnitude of change in overall T-score using the self-report measure, Mayo-Portland Adaptability Inventory (MPAI-4). The overall T-score range is -38 to 106. Higher scores indicate more severe TBI functional status.
Changes in brain function
Change in resting state functional connectivity will be measured by 12-minutes of resting state functional MRI. Participants will be instructed to keep their eyes open and maintain attention on a white fixation cross on a black screen.
Changes in brain structure
Structural brain integrity will be measured with a high resolution 3D T1-weighted scan with good gray/white matter contrast and a complementary high-resolution T2-weighted anatomical scan.
Changes in task-related brain activation
Change in functional connectivity and brain activation will be measured while performing N-Back Task.

Full Information

First Posted
September 29, 2016
Last Updated
November 30, 2020
Sponsor
Posit Science Corporation
Collaborators
VA Connecticut Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT02922569
Brief Title
Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
Acronym
CogMind
Official Title
Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
September 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
Collaborators
VA Connecticut Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.
Detailed Description
The primary objective of this study is to evaluate the effects of combination of mindfulness training (MT) and adaptive cognitive training (CT) on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with traumatic brain injury (TBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
Computerized plasticity-based adaptive cognitive training and mindfulness training requiring a total maximum of 60 treatment sessions, up to 5 sessions per week, 40 minutes per session.
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Commercially available computerized training and traumatic brain injury information session requiring a total maximum of 60 treatment sessions, up to 5 sessions per week, 40 minutes per session.
Intervention Type
Other
Intervention Name(s)
Computerized Plasticity-Based Adaptive Cognitive Training
Intervention Description
Thirty minutes of training on computerized exercises that targets processing speed, memory and attention.
Intervention Type
Other
Intervention Name(s)
Commercially available computerized training
Intervention Description
Thirty minutes of training on computerized, casual video games.
Intervention Type
Other
Intervention Name(s)
Mindfulness Training
Intervention Description
Ten minutes of using an online training course that teaches skills to help overcome ongoing life stressors.
Intervention Type
Other
Intervention Name(s)
Traumatic Brain Injury Information Session
Intervention Description
Ten minutes of viewing traumatic brain injury related news, information, and programs.
Primary Outcome Measure Information:
Title
Changes in performance on global cognitive composite score
Description
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
Time Frame
At 3 months and at 6 months
Secondary Outcome Measure Information:
Title
Changes in performance on processing speed composite score
Description
Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks.
Time Frame
At 3 months and at 6 months
Title
Changes in performance on memory composite score
Description
Change in performance on memory will be measured using the composite score created by averaging the z-scores of N-Back task, Spatial Working Memory task, WAIS-IV Digit Span and Rey Auditory Verbal Learning Test (RAVLT).
Time Frame
At 3 months and at 6 months
Title
Changes in performance on executive function composite score
Description
Change in performance on executive function will be measured using the composite score created by averaging the z-scores for the Trail Making, Flanker, and Stroop tasks.
Time Frame
At 3 months and at 6 months
Title
Change in functional performance
Description
Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.
Time Frame
At 3 months and at 6 months
Title
Change in TBI functional status
Description
Between-group magnitude of change in overall T-score using the self-report measure, Mayo-Portland Adaptability Inventory (MPAI-4). The overall T-score range is -38 to 106. Higher scores indicate more severe TBI functional status.
Time Frame
At 3 months and at 6 months
Title
Changes in brain function
Description
Change in resting state functional connectivity will be measured by 12-minutes of resting state functional MRI. Participants will be instructed to keep their eyes open and maintain attention on a white fixation cross on a black screen.
Time Frame
At 3 months
Title
Changes in brain structure
Description
Structural brain integrity will be measured with a high resolution 3D T1-weighted scan with good gray/white matter contrast and a complementary high-resolution T2-weighted anatomical scan.
Time Frame
At 3 months
Title
Changes in task-related brain activation
Description
Change in functional connectivity and brain activation will be measured while performing N-Back Task.
Time Frame
At 3 months
Other Pre-specified Outcome Measures:
Title
Change in Neurobehavioral Symptoms
Description
Between-group magnitude of change in sum score using the self-report measure, Neurobehavioral Symptoms Index (NSI). The scoring range is 0-88. Higher scores indicate more severe neurobehavioral symptoms.
Time Frame
At 3 months and at 6 months
Title
Change in PTSD Symptoms
Description
Between-group magnitude of change in sum score using the self-report measure, PTSD Checklist (PCL-5). The scoring range is 0-80. Higher scores indicate more severe PTSD symptoms
Time Frame
At 3 months and at 6 months
Title
Change in Depressive Symptoms
Description
Between-group magnitude of change in sum score using the self-report measure, Beck Depression Inventory (BDI-II). The scoring range is 0-63. Higher scores indicate more severe depressive symptoms.
Time Frame
At 3 months and at 6 months
Title
Change in Health-Related Quality of Life
Description
Between-group magnitude of change in sum score using the self-report measure, Quality of Life after Brain Injury (QOLIBRI). The scoring range is 0-100. Lower scores indicate lower quality of life.
Time Frame
At 3 months and at 6 months
Title
Change in Executive Function Symptoms
Description
Between-group magnitude of change in After total T-score using the self-report measure, Frontal Systems Behavior Scale (FrSBe). Raw scores are converted to age- and education-corrected T-scores. The mean T-score is 50, scores greater than 65 are considered clinically significant.
Time Frame
At 3 months and at 6 months
Title
Change in Cognitive Symptoms
Description
Between-group magnitude of change in sum score using the self-report measure, Cognitive Failures Questionnaire (CFQ). The scoring range is 0-100. Higher scores indicate more severe cognitive symptoms.
Time Frame
At 3 months and at 6 months
Title
Change in Work/School Status
Description
Change in total score using the self-report questionnaire about their work/school status.
Time Frame
At 3 months and at 6 months
Title
Change in Physical Activity
Description
Change in total score based on weekly self-report dairy about physical activity during training period.
Time Frame
At 3 months
Title
Change in Diet
Description
Change in total score based on weekly self-report dairy about diet during training period.
Time Frame
At 3 months
Title
Change in Social Activity
Description
Change in total score based on weekly self-report dairy about social activity during training period.
Time Frame
At 3 months
Title
Change in Sleep
Description
Change in total score based on weekly self-report dairy about sleep during training period.
Time Frame
At 3 months
Title
Change in Functional Abilities
Description
Change in total score based on weekly self-report dairy about functional abilities during training period.
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be 18 years of age or older Participants must have diagnosis of mild traumatic brain injury (mTBI) confirmed by Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF) Participants must have persistent cognitive dysfunction confirmed by an objective measure (Automated Neuropsychological Assessment Metrics (ANAM) TBI Battery with a score at least one standard deviation below the age-adjusted norm for a military sample) or a subjective measure (Ruff Neurobehavioral Inventory (RNBI) with a score of greater than 70 on any of the four cognitive scales (Attention, Memory, Language, Executive) Participants must be at least six months out from their most recent traumatic brain injury (TBI), concussion, and/or blast exposure Participant must be a fluent English speaker Participants must score ≥ 70 on the Wechsler Test of Adult Reading (WTAR) Participants must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse Exclusion Criteria: Participants with history of TBI with loss of consciousness for more than 24 hours or post-traumatic amnesia for more than 7 days Participants with a history of penetrating head wounds Participants who are in-patients Participants with a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis) Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Participants showing signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit Participants with clinically significant visual field deficits Participants judged to be lacking effort Participants with problems performing assessments or comprehending or following spoken instructions Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment for TBI that could affect the outcome of this study Participant with self-reported claustrophobia or physician-reported implanted devices (e.g. pacemakers, cochlear implants, aneurysm clips, etc.) and pregnant women will not be able to participate in MRI portion of study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu Lee, PhD
Organizational Affiliation
Posit Science Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Connecticut Health Care System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI

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